Randomized clinical trials are the gold standard for evaluating the efficacy and safety of medicines, but they come with many drawbacks including high monetary and time costs, a lack of representation compared to the general public, and ethical limitations. Historically, these trials were the main mechanism to understand the effects of a medicine. But more recently, real world data from sources such as electronic health records, insurance claims and billing activities, disease registries, and wearable devices, is having a greater effect on understanding a medicine’s usage and effects. Although this information is collected outside of clinical trials, clinical researchers incorporate it during the earliest phases of clinical development to gain additional information and speed up the drug development process. In this episode, we talk to Brian Bradbury, vice president of the Center for Observational Research at Amgen, about the increased utilization of real world data and its potential to revolutionize every stage of clinical research, from trial design to regulatory requirements and outcomes measurement.

Speaker
Brian Bradbury, PhD
Vice President
Center for Observational Research
Amgen